Seems to me they're going after immunos. To my recollection, there are
only a very few kits that have FDA approval. I would think it's going to
be more a manufacturer problem than a lab problem. I doubt they would go
after the labs when they can go after Roche and Agilent (Ventana and
Dako).
Histonet does not allow attachments.
-Original Message-
From: Histology via Histonet
Sent: Wednesday, June 26, 2024 8:13 AM
To: Paula ; histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] LDT's Regulatiions by the FDA
EXTERNAL SENDER - Exercise caution with requests, links, and
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Can I ask you to provide an example of a laboratory developed test? So
we're all on the same page.
A test that you are not buying from a vendor, but just a totally in house
protocol, reagents, etc?
Using a vendor's test kit off label?
Would a simple special stain like a PAS qualify as a LDT if
I don't see the attachment. Can you try again?
Mehndi Helgren
Lab Manager
757-664-7901
Dominion Pathology Labs.
733 Boush St. Suite 200
Norfolk, VA 23510
-Original Message-
From: Paula via Histonet
Sent: Tuesday, June 25, 2024 2:23 PM
To: histonet@lists.utsouthwestern.edu
